Induction therapy of AML with ara-C plus daunorubicin versus ara-C plus gemtuzumab ozogamicin: a randomized phase II trial in elderly patients

被引：33

作者：

Brunnberg, U. ^{[2
]}

Mohr, M. ^{[1
]}

Noppeney, R. ^{[3
]}

Duerk, H. A. ^{[5
]}

Sauerland, M. C. ^{[4
]}

Mueller-Tidow, C. ^{[1
]}

Krug, U. ^{[1
]}

Koschmieder, S. ^{[1
]}

Kessler, T. ^{[1
]}

Mesters, R. M. ^{[1
]}

Schulz, C. ^{[1
]}

Kosch, M. ^{[6
]}

Buechner, T. ^{[1
]}

Ehninger, G. ^{[7
]}

Duehrsen, U. ^{[3
]}

Serve, H. ^{[2
]}

Berdel, W. E. ^{[1
]}

机构：

[1] Univ Hosp Muenster, Dept Med Hematol & Oncol A, D-48149 Munster, Germany

[2] Univ Hosp Frankfurt, Dept Med Hematol & Oncol, Frankfurt, Germany

[3] Univ Hosp Essen, Dept Med Hematol & Oncol, Essen, Germany

[4] Univ Munster, Inst Biostat & Clin Res, Munster, Germany

[5] St Marien Hosp, Hamm, Germany

[6] Pfizer Pharma GmbH, Berlin, Germany

[7] Univ Hosp Dresden, Dept Med Hematol & Oncol, Dresden, Germany

来源：

ANNALS OF ONCOLOGY | 2012年 / 23卷 / 04期

关键词：

AML in elderly; gemtuzumab ozogamicin; induction therapy; Mylotarg; ACUTE MYELOID-LEUKEMIA; HIGH-DOSE CYTARABINE; STEM-CELL TRANSPLANTATION; VENOOCCLUSIVE DISEASE VOD; COOPERATIVE-GROUP; INTENSIVE CHEMOTHERAPY; PROLONGED MAINTENANCE; DEFIBROTIDE DF; OLDER PATIENTS; CONSOLIDATION;

D O I：

10.1093/annonc/mdr346

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Chemotherapy for elderly patients with acute myeloid leukemia (AML) results in a median overall survival (OS) of <= 1 year. Elderly patients often present with cardiac comorbidity. Gemtuzumab ozogamicin (GO) is active in elderly (60 years) patients with relapsed AML with low cardiac toxicity. Patients and methods: This randomized phase II study compared a standard combination of ara-C and daunorubicin (DNR; 7+3) versus ara-C plus gemtuzumab ozogamicin (7+GO) as the first course of induction therapy. Primary objectives were comparison of blast clearance on day 16, event-free survival (EFS), and remission duration. OS, complete remission (CR), and tolerability were secondary objectives. Results: One hundred and nineteen patients with de novo AML, treatment-related AML, AML with a history of myelodysplastic syndrome (MDS), or high-risk MDS entered the study. Median age of 115 patients (intent-to-treat population) was 69 years. Protocol outlined a second course 7+3 for patients without blast clearance and two courses of high-dose ara-C consolidation upon CR. Both treatments were equally effective in blast clearance, CR, EFS, remission duration, or OS (median: 7+3, 9 months; 7+GO, 10 months). Induction death rate was higher in the GO group due to veno-occlusive disease. Conclusion: The study did not show significant superiority of 7+GO over standard 7+3.

引用

页码：990 / 996

页数：7

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